Phase 4
Completed N=110
Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo
Source: ClinicalTrials.gov NCT00749944 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: Change From Baseline in the Profile of Mood States (POMS): Total Mood Disturbance (TMD) — 0.06; -0.66; 0.30; -0.17 scores on a scale
Summary
Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Profile of Mood States (POMS): Total Mood Disturbance (TMD) |
0.06; -0.66; 0.30; -0.17; 0.95; 0.03 | — |
| PRIMARY Change From Baseline in the Profile of Mood States (POMS): Tension-Anxiety Subscale |
0.30; -0.31; 0.15; -0.26; 0.31; -0.18 | — |
| PRIMARY Change From Baseline in the Profile of Mood States (POMS): Depression-Dejection Subscale |
0.38; -0.24; 0.50; -0.24; 0.56; -0.10 | — |
| PRIMARY Change From Baseline in the Profile of Mood States (POMS): Anger-Hostility Subscale |
0.16; -0.69; -0.04; -0.89; 0.24; -1.00 | — |
| PRIMARY Change From Baseline in the Profile of Mood States (POMS): Vigor Subscale |
0.16; 0.98; -1.34; -1.15; -3.30; -1.14 | — |
| PRIMARY Change From Baseline in the Profile of Mood States (POMS): Fatigue Subscale |
-0.14; -0.65; -0.29; -0.83; -0.58; -0.76 | — |
| PRIMARY Change From Baseline in the Profile of Mood States (POMS): Confusion Subscale |
0.14; -0.09; 0.03; -0.18; 0.10; -0.11 | — |
| PRIMARY Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score |
1.05; 0.83; 2.28; 1.84; 1.19; 1.41 | — |
| PRIMARY Change From Baseline in the Hamilton Anxiety Scale (HAM-A): Total Score |
1.01; 0.75; 2.69; 2.16; 1.95; 1.86 | — |
| PRIMARY Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Aggression Total Score |
0.13; 0.48; 0.82; 0.72; 2.24; 0.75 | — |
| PRIMARY Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score |
0.01; 0.01; 0.43; 0.41; 0.46; 0.35 | — |
| PRIMARY Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score |
— | — |
| PRIMARY Change From Baseline in the Social Dysfunction and Aggression Scale (SDAS): Total Score |
— | — |
| PRIMARY Change From Baseline in the Barratt Impulsiveness Scale - Version 11 (BIS-11): Total Score |
0.34; -0.07; 0.45; 0.37; 1.34; 1.28 | — |
| SECONDARY Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Total Score |
0.13; 0.05; 0.10; 0.11; 0.07; 0.05 | — |
| SECONDARY Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Negative Affect Domain Subscale |
0.06; 0.01; 0.10; 0.09; 0.07; 0.03 | — |
| SECONDARY Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Insomnia Domain Subscale |
0.07; 0.12; 0.15; 0.17; 0.04; 0.10 | — |
| SECONDARY Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Urge to Smoke Subscale |
-0.60; -0.29; -1.40; -0.97; -2.17; -2.03 | — |
| SECONDARY Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Restlessness Subscale |
0.06; 0.08; 0.10; 0.11; 0.09; 0.04 | — |
| SECONDARY Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Increased Appetite Subscale |
0.14; 0.02; 0.10; 0.12; 0.11; 0.15 | — |
| SECONDARY Number of Participants Exceeding Thresholds for the Profile of Mood States (POMS): Total Score |
14; 11; 32; 35; 37; 38 | — |
| SECONDARY Number of Participants Exceeding Thresholds for the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score |
2; 0; 7; 3; 8; 3 | — |
| SECONDARY Number of Participants Exceeding Thresholds for the Hamilton Anxiety Scale (HAM-A): Total Score |
0; 2; 9; 7; 12; 7 | — |
| SECONDARY Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Agression Total Score |
9; 6; 20; 21; 21; 23 | — |
| SECONDARY Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score |
10; 11; 32; 34; 36; 36 | — |
| SECONDARY Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score |
— | — |
| SECONDARY Number of Participants Exceeding Thresholds for the Barratt Impulsiveness Scale - Version 11 (BIS-11): Total Score |
1; 0; 1; 2; 1; 2 | — |
| SECONDARY Number of Participants Exceeding Thresholds for the Social Dysfunction and Aggression Scale (SDAS): Total Score |
2; 1 | — |
| SECONDARY Number of Participants With Carbon Monoxide Confirmed Daily Smoking Cessation |
16; 10 | — |
| SECONDARY Number of Participants With 7-day Point Prevalence of Abstinence (Smoking Cessation) |
19; 16; 23; 12; 20; 17 | — |
| SECONDARY Change From Baseline in the Number of Cigarettes Smoked Per Day |
-0.1; -0.2; -0.6; 0.0; -1.8; -0.3 | — |
Eligibility Criteria
Inclusion Criteria
- smokers who smoke >10 cigarettes/day and who have at least a moderate level of addiction as measured by the Fagerstrom Test for Nicotine Dependence (score >5)
Exclusion Criteria
- Any neuropsychiatric disease including depression, history of suicidal thoughts or behavior, bipolar disorder.
- Any unstable medical condition
Data sourced from ClinicalTrials.gov (NCT00749944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.